Flexible sterile bags intended for receiving a biopharmaceutical fluid are known. These flexible sterile bags are handled frequently in a large number of operations, for example during filling, freezing, storage, transport, thawing, draining, etc. In particular, during the transport phases, for example by boat, plane, or truck, there is a risk of the bag being damaged and its integrity compromised if it is not properly protected. Bag leakage can occur, resulting in a loss of the biopharmaceutical fluid it contains as well as a loss of sterility.
Also, in order to carry out the transport operations described above, it is known to use devices that allow receiving the bag containing the pharmaceutical fluid and then transporting it in a secure manner.
In a first known embodiment, a device comprises a rigid container in which is placed one or more bags filled with biopharmaceutical fluid. The device thus allows maintaining and protecting the bag or bags during transport. However, significant stresses can be generated in the bag, for example due to movement of the biopharmaceutical fluid inside it. In addition, when the bag comprises rigid elements such as ports or connectors for fill or discharge tubes, these can strike the inner wall of the container if there are impacts, vibrations, or turbulence during transport operations. This can exert significant mechanical stress at the wall of the bag, particularly at the sites for attachment of rigid tubing to the wall of the bag, which can be sufficient to rupture the bag or cause damage likely to compromise its integrity.
In a second embodiment, the device may further comprise bubble wrap and/or foam placed on the inner wall of the rigid container to prevent impacts between the bag and the container during transport. However, for cost reasons, it is often preferable to use containers of standard sizes for the transport of flexible bags of various sizes. Also, when the container is not of a size specifically adapted to that of the bag, free space remains between the inner wall of the container and the bag so that the bag is not properly held in place. This can occur as well when the container is adapted for a size of flexible bag having a certain predefined fill level but the bag is underfilled or overfilled relative to this predefined fill level. The bag is then able to move within the container under the effect of external stresses and can rupture when it strikes the container wall.
In a third embodiment, the device may consist of a protective shell in which the bag is suspended, thus distancing it from the inner wall of the shell. However, such a device is complex to implement because the shell must comprise internal means for suspending the bag. It is also necessary to ensure that no part of the bag is in contact with the shell, which can be tedious and time-consuming when the suspension of a large number of bags must be checked prior to transport.
There is therefore a need, in the specific field of the invention, to be able to transport bags of biopharmaceutical fluid easily and securely.